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The SANSIN Tubing Sets for Hemodialysis are single-use sterile medical devices intended to connect the patient to the hemodialyzer and the hemodialysis delivery system in hemodialysis treatment. The compatibility of available configurations is the responsibility of the physician/clinician in charge.

The propose device, SANSIN Tubing Sets for Hemodialysis, is used to connect the patient to the hemodialyzer and the hemodialysis delivery system in hemodialysis treatment. The proposed devices are provided sterile and single use. The proposed device is intended to be used with Fresenius 2008K Home Hemodialysis manufactured by Fresenius Medical Care North America, which is a hemodialysis delivery system being submitted to FDA for premarket notification (K124035). The proposed device mainly consists of two tubes, which are arterial line with certain components in red and venous line with certain components in blue, as well as accessories such as priming piece, drain bag, priming needle, fluid replacement tube, connecting tube, monitor and transducer protector. The proposed devices are available in various specifications. Based on the different volume of air capture chamber, there are five models HDJ, HDK, HDL, HDM and HDN.

The non-sterile disposable medical face masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile. The sterile disposable medical face masks are intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.

The proposed device. Disposable medical face masks, is provide in sterile and non-sterile two types. Both the non-sterile disposable medical face masks and sterile disposable medical face masks are available in five sizes, which are 95mm×155mm, 95mm×140mm, 95mm×145mm and 95mm×160mm. And both the non-sterile disposable medical face masks and sterile disposable medical face masks are available in two ear strap types, Type A, which is ear-loop type, and Type B, which is tie-on type.

The proposed device, I.V. Catheter, is intended to be inserted in to a patient's vascular system for short term use (no more than 72 hours) to withdraw blood samples or administer fluid intravenously.

The proposed devices, I.V. Catheters, are sterile, single use devices intended to be inserted in to a patient's vascular system for short term use to withdraw blood samples or administer fluid intravenously. The I.V. Catheter is a closed system, and further available in two combinations of configurations. All of them are sterilized by Ethylene Oxide to achieve a SAL of 106, and packed in a sterility maintenance package. The shelf life of the product is three years.